Posts tagged with: "fda"
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19 Oct 2022, 10:00 pm
They typically establish FDA policy and interpretation where there is a need for clarification or to address other issues not covered by existing FDA laws, regulations, or guidance. [read post]
21 Jul 2016, 5:44 pm
The FDA has just released a statement that signals a turn in the tide against the makers of WEN. [read post]
31 Jan 2023, 9:03 pm
Robert Califf, the Reagan-Udall Foundation for the FDA (FDA Foundation) launched an external evaluation of the FDA’s Human Foods Program on September 8, 2022. [read post]
7 Nov 2008, 10:37 pm
This past Thursday, FDA sent US marshals to seize 11 lots of the heparin drug. [read post]
20 Oct 2006, 7:19 am
Drug-eluting stents marketed by Boston Scientific Corp. and Johnson & Johnson will be discussed at a Dec. 7 and 8 FDA meeting.The FDA announced the dates for a previously discussed meeting to look at whether drug-coated stents may actually increase the risk of deadly blood clots. [read post]
2 Nov 2015, 5:55 am
Here is a good and recent Warning Letter from FDA. [read post]
13 May 2007, 11:28 pm
The FDA is not required to follow an advisory panel's advice, but it often does. [read post]
5 Dec 2022, 4:15 pm
Failing to do so could result in an FTC and/or FDA investigation. [read post]
12 Mar 2008, 1:00 pm
In recent years, owners of branded drugs approved by the FDA have sometimes filed Citizen Petitions on the eve of FDA approval of generic equivalents. [read post]
9 Mar 2016, 1:34 pm
FDA, 119 F. [read post]
23 Dec 2017, 6:29 am
The Chicago Tribune adds, “The FDA issued a notice in January that St. [read post]
11 Dec 2008, 11:01 am
What did the FDA panel hear? [read post]
15 Dec 2021, 9:08 pm
FDA formed a CBD Policy Working Group in April 2019. [read post]
7 Apr 2020, 8:23 am
If you take ranitidine, you should be aware that the Food and Drug Administration (FDA) asked manufacturers to withdraw the medication from the market last week (FDA Requests Removal of All Ranitidine Products (Zantac) from the Market, April 1, 2020). [read post]
7 Mar 2009, 8:01 am
Is this too much for FDA right now? [read post]
17 Dec 2018, 12:23 pm
The FDA’s 510(k) fast-track program is causing more problems than it solves. [read post]
2 Feb 2021, 7:23 pm
Additionally, the FDA has issued recommendations and policies about PPE which can be found here: Recent Final Medical Device Guidance Documents…” [read post]
28 Feb 2020, 8:42 am
Bergeson On February 24, 2020, FDA Commissioner Stephen M. [read post]
2 Feb 2023, 11:33 am
But this time we are going to zoom in on FDA and FTC issues. [read post]
18 Aug 2009, 4:41 am
In addition to suing FDA over its... [read post]